MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, VISIONPRO 26" LED DISPLAY; CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO

Model Number	0240031020
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that there was image loss during procedure.Please note that the procedure was completed successfully with no reports of adverse consequences, medical intervention or surgical delay.
Event or Problem Description
It was reported that there was image loss during procedure.Please note that the procedure was completed successfully with no reports of adverse consequences, medical intervention or surgical delay.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.The reported failure mode will be monitored for future reoccurrence.Alleged failure: lost image: probable root cause: tx main board.Tx power supply.Spi3 expansion slot card.Connectors.Tx software/vxp firmware.Use error.Electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge.Manufacturing/ service nonconformity.Connected console malfunction.Manufacture date is not known.H3 other text : 81.

• Brand Name: PKG, VISIONPRO 26" LED DISPLAY
• Common Device Name: CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10414579
• Report Number: 0002936485-2020-00344
• Device Sequence Number: 19306927
• Product Code: FWB
• UDI-Device Identifier: 07613327056082
• UDI-Public: 07613327056082
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0240031020
• Device Catalogue Number: 0240031020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1